Medical/surgical devices

ABSTRACT

A securing device for medical and surgical use has two parts which may be separate or integrally connected, one part including an eye (3) with a latching pawl (4) and the other part including a flexible strip (1) with ratchet teeth (2) so that the strip can be advanced through the eye to adjust the effective length of the flexible strip, but is locked against reverse movement. In one embodiment the parts are integral and a needle (7) is attached to the free end of the flexible strip, the device being a surgical suture. In another embodiment the parts are separate and are adapted to engage respective body parts of a patient which are to be held together by the device.

BACKGROUND OF THE INVENTION

The invention is concerned with devices for medical and especially, butnot necessarily exclusively, surgical applications. More particularly,the invention relates to such a device for attachment to a patienteither for connecting together body parts, e.g., for closing woundsproduced during surgical procedures, or for securing an externalcomponent, such as a cannula, to a body part to prevent accidentaldisplacement.

The most common technique employed for wound closure during surgicaloperations is that of stitching using either nylon or other plasticthread or stainless steel wire where greater strength is required.Stitching is often complicated by the need to tie knots which must bereliable and not slip, and this frequently prolongs the time taken tocomplete an operation, thereby adding to the stress and trauma impartedupon the patient. Furthermore, it is sometimes necessary to apply acertain tension between body parts being connected together, which isdifficult to achieve when conventional stitching methods are reliedupon, whereby substantial skill is required on the part of the surgeon.

In U.S. Pat. No. 4,874,370 there is disclosed a securing strip forencircling a section of intestine to hold it onto a tubular adaptorinserted into the section of intestine. The securing strip has teeth anda channel portion at one end with complementary depressions so that thestrip can be formed into a loop and tightened, the other end of the tiehaving a ring tab to assist tightening. This strip functions like a wellknown cable tie for holding together bundles of electric cables and itdoes not provide an answer to the drawbacks mentioned above.

SUMMARY OF THE INVENTION

The present invention addresses these drawbacks and as a solution itproposes a medical securing device comprising an elongate first part inthe form of a flexible strip having a free end and having ratchet meansprovided therealong, and a second part including an eye for the free endto be passed therethrough, the eye including latching means arranged tocooperate with the ratchet means to permit forward movement of the stripthrough the eye but to retain the strip securely against reversemovement through the eye, thereby to enable the effective length of thefirst part to be adjusted, characterised in that the first part hasfixed thereto means for use in attaching the first part to a body partof a patient and/or for connecting another external member thereto.

According to a first embodiment of the securing device adapted for woundclosure, a needle (or stylet) is fixed to the free end of the flexiblestrip, and the eye is integrally connected to the other end of thestrip. The needle is used to thread the flexible strip through, e.g.,tissue segments to be sutured, and is then passed through the eye tolead the free end of the strip therethrough, whereby the strip is formedinto a loop. The strip is pulled through the eye until the requiredtension is obtained in the loop and thereafter the needle, and possiblythe excess length of strip protruding through the eye, is cut away. Suchan embodiment facilitates the application of reliable sutures and alsoallows accurate control over the suture tension. It may be applied withconsiderable advantage in the closure of abdominal wounds, for closingtogether the sternum and in other similar procedures.

In accordance with another embodiment of the invention, the devicecomprises first and second parts which are separate and adapted forengagement with respective body parts or segments. When the two parts ofthe device have been engaged with the respective segments the flexiblestrip can be advanced through the eye to reduce the effective length ofthe strip and put the strip under tension. A device of this form couldbe used to advantage, for example, in repairing or rebuilding a rupturedorgan, such as a liver, by being applied to span a split in the organand to hold the split closed so that it may heal together. Anotherpossible application may be in mending fractured bones with the devicebeing fitted to the bone to span the fracture and being tightened tohold the bone segments together for healing. From the foregoing it willbe appreciated that the two parts of the device may be provided withvarious means, formed integrally or fastened thereto, for connectingthem to body parts as desired by the particular surgical application towhich the device is to be put, such as studs for socketing into bone,bars or plates for attachment to organs, muscle tissue etc., or elementsof other configurations.

According to another embodiment of the invention the eye is integralwith the end of the flexible strip opposite the free end, and at aposition intermediate its ends the strip has means integral therewithand projecting laterally therefrom for engagement with an externalmember, e.g. a cannula in which case the integral means may comprise acollar or C-shaped clip. This embodiment may be applied around a limb,e.g. the arm of a patient, under light tension, and serve to hold acannula or other external element fitted to the patient against mainunintentional detachment or displacement.

BRIEF DESCRIPTION OF THE DRAWINGS

A better understanding of the invention will be had from the followingdetailed description of some embodiments, reference being made to theaccompanying drawings, in which:

FIG. 1 is a schematic longitudinal cross-section through a suturingdevice according to the invention;

FIG. 2 is a perspective view showing a suture device for a femaleincontinence sling procedure;

FIG. 3 is a perspective view showing another embodiment of a suturedevice for a female incontinence sling procedure; and

FIG. 4 shows a plan view of the sling member of the device of FIG. 3.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The surgical suture device shown in FIG. 1 comprises an integrallymoulded member comprising a flexible strip 1 formed with a series ofratchet teeth 2 extending along a major part of its length (forconvenience not all of the teeth are shown), and a generally rectangulareye 3 integral with a trailing end of the strip 1 and incorporating anintegral latching finger or pawl 4 for engagement with the teeth 2 asshown to lock the strip 1 against reverse movement through the eye whilepermitting substantially unopposed forward movement of the strip, thepawl 4 being hinged at 5 to permit such forward movement. As so fardescribed the moulded member is of a construction known per se, suchmembers being commonly known as cable ties and being used to holdtogether bundles of electric cables and for other such purposes.

In the device of FIG. 1, the moulded member is provided at its free endwith an integral tongue 6 onto which is fixed a tubular stylet or needle7. As shown the needle is curved, but a straight needle is alsopossible. The needle is fastened securely to the tongue by crimping, orby any other convenient method, such as moulding the strip onto theneedle.

Prior to use, the strip 1 is generally ly rally straight and it does notextend through the eye 3. The needle 6 is used to lead the strip 1through the tissue segments to be sutured, and is then passed throughthe eye 3 to form the strip 1 into a closed loop, as seen in FIG. 1. Thestrip is advanced through the eye until the required tension is obtainedin the loop. The needle, and the excess strip protruding from the eyeare then cut off and discarded. To facilitate the closing and tighteningof the loop, the eye 3 is provided with means to enable it to be grippedin the jaws of a pair of forceps. As shown this means is constituted bya lip or flange 8 at the side of the eye opposite that side to which thestrip 1 is attached, and the surfaces of this lip may be knurled orserrated to enhance the gripping action of the forceps, and/or the lipmay have a hole therethrough so that it can be easily held withsmall-nosed medical forceps. Of course the eye may be provided withalternative formations to enable it to be gripped, e.g., a recess in theside wall defining an edge with which the forceps jaws may be engaged,or an elongate filament, say 2-3 cms long, forming a tail which may betwisted onto small remote controlled surgical tools as used innon-invasive micro-surgery.

The suture device shown in FIG. 1, is quick and simple to apply andallows easy control of the suture tension. The moulded member formingthe strip 1 and eye 3 may be made from medical grade nylon, or perhaps abiodegradable polymer so that it will in time become absorbed in thebody.

In FIG. 2 there is illustrated a suture device for a female incontinencesling procedure. The device is formed in three separate parts, the firsttwo parts 10 being essentially identical ties and each taking the formof a flexible strip 11 with ratchet teeth 12 along its length, anintegral tapered tip 13 at the leading end of the strip and a transverseanchoring bar 14 integral with the trailing end of the strip. The otherpart of the device consists of a relatively stiff bar 15 having anintegral eye 16 at each end. The eyes are equipped with latching pawls17, in the same manner as the eye 3 in the FIG. 1 suture device, so thatthe strips 11 of the respective parts 10 may be inserted through theeyes 16 and will become automatically locked against reverse movementdue to the engagement of the latching pawls 17 with the ratchet teeth12. All three parts of the device can be moulded from medical gradenylon.

In application of the device the two parts are introduced through thevagina of the patient and are directed upwardly through the smallincisions so that the anchorage bars 14 become engaged in tissue oneither side of the urethra. The cross bar 15 is implanted subcutaneouslyat a lower abdominal region so that the tips 13 can be fed through therespective eyes 16. The tips 13 and flexible strips 11 attached theretoare pulled through the eyes to adjust the effective length of the strips11 between the anchorage bars 14 and the cross bar 15, and thereby thetension in the strips 11, so that the urethra is lifted and normalconstitution of the bladder neck anatomy is restored. The latchingsystem provided by the pawl and ratchet teeth enables accurateadjustment of the length and tension of the tie strips. The leading endsof the strips above the cross bar 15 can be cut off and discarded afterthe suture device has been fitted and adjusted.

In addition to making such sling procedures easier and quicker toperform, the suture device of the invention has the added benefit thatif further laxity should occur, the sling device can be adjusted bytightening up the ties 10 by advancing them through the eyes.

If preferred a web of Dacron or net could be arranged to extend betweenthe anchorage bars 14 and pass beneath the urethra for directlysupporting it from below. Shown in FIG. 4, is an alternative form ofsling procedure suture in which such a web or sling is integral with thetie parts. Thus, in place of the bars 14, the two flexible strips 11 arefastened to opposite sides of a web 20 which has a mesh-like structure.In all other respects the device is as described above with reference toFIG. 2. Although the strips 11 are shown to be in longitudinalalignment, they may be arranged at an angle e.g. as depicted in brokenline in FIG. 4, so that the web will be better oriented for supportingthe urethra.

It will be appreciated that the invention is not restricted to theparticular embodiments described above and the novel principles involvedare applicable to a wide variety of different devices adapted fordiffering medical or surgical duties. However, the invention isespecially advantageous where a suture with an effective length whichcan be gradually reduced, e.g. to adjust the tension, is desirable.

We claim:
 1. A surgical suture device comprising an elongate flexiblestrip having ratchet means provided therealong, a complete annular eyeintegral with one end of the strip, a needle fastened to the other endof the strip, the needle being insertable through the eye to form thestrip into a loop and the eye having latching means arranged to permitforward movement of the strip through the eye to reduce the size of theloop but to restrain the strip securely against reverse movement throughthe eye, wherein:the eye defines a lengthwise extension of the stripwhereby a strip portion extending through the eye is substantiallyperpendicular to the strip end portion attached to the eye; and the eyehas integral, one piece flattened holding means projecting therefrom ina direction away from the strip for engagement by a gripping tool; andthe needle has a tubular trailing end in which is fixed a tongueintegral with said other end of the strip.
 2. A surgical suture deviceaccording to claim 1, wherein the tongue is fixed in the needle bycrimping.
 3. A surgical suture device according to claim 2, wherein theholding means comprises a flange.
 4. A surgical suture device comprisingan elongate flexible strip having ratchet means provided therealong, aneye integral with one end of the strip, a needle fastened to another endof the strip, the needle being insertable through the eye to form thestrip into a loop and the eye having latching means arranged to permitforward movement of the strip through the eye to reduce the size of theloop but to restrain the strip securely against reverse movement throughthe eye, wherein:the eye defines a lengthwise extension of the stripwhereby a strip portion extending through the eye is substantiallyperpendicular to the strip end portion attached to the eye; the eye hasan integral flange projecting therefrom in a direction away from thestrip; the flange has a hole therein for cooperation with a grippingtool; and the needle has a tubular trailing end in which is fixed atongue integral, one piece with said other end of the strip.
 5. Amedical securing device for attachment to a patient comprising a pair ofelongate first parts, each in the form of a flexible strip having a freeend, a member integrally connected in one piece to another end forsecuring the flexible strip to a body part of a patient, and havingratchet means provided therealong, and a separate second part includingtwo eyes for the free ends of the respective flexible strips to bepassed therethrough, each said eye including latching means arranged tocooperate with the ratchet means to permit forward movement of the stripthrough the eye but to retain the strip securely against reversemovement through the eye, thereby to enable the effective length of therespective first part to be adjusted, and wherein the first parts areseparate and each said member comprises an elongated bar having alongitudinal axis extending transversely of the flexible strip.
 6. Amedical securing device for attachment to a patient comprising a pair ofelongate first parts, each in the form of a flexible strip having a freeend, a member integrally connected in one piece to another end forsecuring the flexible strip to a body part of a patient, and havingratchet means provided therealong, and a separate second part includingtwo eyes for the free ends of the respective flexible strips to bepassed therethrough, each said eye including latching means arranged tocooperate with the ratchet means to permit forward movement of the stripthrough the eye but to retain the strip securely against reversemovement through the eye, thereby to enable the effective length of therespective first part to be adjusted, and wherein the respectiveflexible strips are connected to a common member forming a sling means,the sling means comprising a generally rectangular mesh having theflexible strips integrally connected in one piece with opposite sidesthereof.